510(k) K000512
K000512 is an FDA 510(k) premarket notification submitted by Cas Medical Systems, Inc. for the device "OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010". The FDA issued a decision of Substantially Equivalent on Sep 26, 2000. The device falls under product code DXQ (Blood Pressure Cuff), a Class II device regulated under 21 CFR 870.1120. Cas Medical Systems, Inc. has 31 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 26, 2000
- Date Received
- Feb 16, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Blood Pressure Cuff
- Device Class
- Class II
- Regulation Number
- 870.1120
- Review Panel
- CV
- Submission Type
- 510(k)
A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.